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Completed

NCT Number: NCT03394352

Exercise Activity-Based Bolus Decisions in Type 1 Diabetes

The purpose of the study is to demonstrate safety and feasibility of a decision support system aimed at improving activity-related insulin boluses in Type 1 Diabetes.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

About this study

Subjects with Type 1 diabetes often need to adjust insulin boluses for activity since activity may increase the chance of hypoglycemia. The aims of this study is to make better bolus decisions by integrating knowledge about daily physical activity (PA) into bolus decisions. It is expected to decrease risk of hypoglycemia related to previous PA and provide better glucose control. The idea is to first obtain a carbohydrate ratio that is optimized around the everyday activity level of the patient and then adjust boluses when the activity for the day is different (above or below) than their regular activity level.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 1 Diabetes for at least one year
  • Using an insulin pump for at least 6 months
  • Age 18-65
  • Uses insulin parameters such as carbohydrate ratio and correction factors consistently on the insulin pump in order to dose insulin for meals or corrections
  • Access to internet and willing to upload data during the study
  • Willingness to maintain consistent activity regimen for 28 day collection period
  • Females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while participating in the study. A negative urine/blood pregnancy test will be required for all women of child bearing potential. Subjects who become pregnant will be discontinued from the study.
  • Demonstration of proper mental status and cognition for the study.
  • An understanding of and willingness to follow the protocol and sign the informed consent.

Exclusion criteria

  • Diabetic ketoacidosis (DKA) in the 6 months prior to enrollment.
  • Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment.
  • Pregnancy and intent to become pregnant during trial.
  • Use of acetaminophen is not allowed when CGM is in use
  • Use of non-insulin medications intended to lower glucose (e.g. glucagon-like peptide [GLP]-1 agonists, metformin)
  • Currently uses a clearly defined method for insulin bolusing to compensate for significant activity (e.g. marathon runner who uses temporary basal rates routinely and has separate basal profiles to account for exercise)
  • Inability to be physically active for more than 30 minutes per day.
  • Current enrollment in another intervention clinical trial.

Treatment and study plan

Activity on Board

Other

During the collection phase, the study team will collect information on glucose values, activity measures and insulin settings. This information will be used to determine the meal and correction boluses during the study admission. Subjects will wear a continuous glucose monitor during the data collection phase and study admission.

Usual diabetes care

Other

Subjects will perform their usual diabetes care including basal rate, meal and correction boluses during the study admission. Subjects will wear a continuous glucose monitor during the study admission.

Primary outcomes

  1. Continuous Glucose Monitor metrics

    Time frame: about 9-12 hours

    Record CGM metrics with the primary outcome analysis of percentage time <70 mg/dL by CGM following exercise comparing the experimental to control admission

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • DexCom, Inc.
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

A Pilot Study of Activity-Based Bolus Decisions in Type 1 Diabetes

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 9, 2018
Registry last updated
May 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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